Artificial Intelligence to Predict Pathology and Endoscopic Classification of Colorectal Polyps During Colonoscopy
Led by Peking Union Medical College Hospital · Updated on 2025-01-14
400
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1
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99 weeks
Total Duration
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What this Trial Is About
Researchers are evaluating an artificial intelligence (AI) model to predict the pathology and endoscopic classification of colorectal polyps during colonoscopy. Colonoscopy with optical diagnosis helps guide treatment and reduce unnecessary procedures, easing the burden on patients and healthcare systems. While current methods require extensive training and have limitations in accurately diagnosing all polyp types, AI-based computer-aided diagnosis (CADx) is rapidly developing and has shown promising accuracy for small lesions under 5mm. However, its effectiveness for larger polyps and serrated lesions, which are precancerous and more difficult to assess, remains unclear.
The study involves developing an AI model using a large dataset of approximately 1600 cases, including serrated lesions, hyperplastic polyps, conventional adenomas, and early-stage colorectal cancer, collected retrospectively from pathology records. The model is built using popular AI classification algorithms and trained on static images linked to pathological diagnoses and endoscopic classifications. After optimization, the AI model's performance will be compared with that of endoscopists in a prospective cohort to assess its diagnostic accuracy.
Participants are adults aged 18 years or older undergoing routine colonoscopy screening at multiple hospital centers who understand the study and provide consent. Researchers will collect data during colonoscopy and compare AI predictions to pathological outcomes. The main outcome measured is the accuracy of the AI optical diagnosis for colorectal polyps over two years. The study excludes individuals with certain serious health conditions, pregnancy, or prior colorectal surgery to ensure participant safety and data reliability.
CONDITIONS
Official Title
AI in Predicting Polyp Pathology and Endoscopic Classification
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Outpatients or inpatients undergoing routine colonoscopy screening at the endoscopy centers of multicenter hospitals
Aged 18 years or older
Have understanding of the study content and have signed the informed consent form
You will not qualify if you...
Gastroparesis or gastric outlet obstruction
Known or suspected intestinal obstruction or perforation
Severe chronic renal failure (creatinine clearance less than 30 mL/minute)
Severe congestive heart failure (New York Heart Association Class III or IV)
Currently pregnant or breastfeeding
Toxic colitis or megacolon
Poorly controlled hypertension (systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 100 mmHg)
Moderate or massive active gastrointestinal bleeding (>100 mL/day)
Significant psychiatric or psychological illness
Allergy to medications used for bowel preparation
Patients who have undergone colorectal surgery
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Narrow band imaging optical diagnosis of small colorectal polyps in routine clinical practice: the Detect Inspect Characterise Resect and Discard 2 (DISCARD 2) study.
Development and validation of the WASP classification system for optical diagnosis of adenomas, hyperplastic polyps and sessile serrated adenomas/polyps.
Joep E G IJspeert, Barbara A J Bastiaansen, Monique E van Leerdam...
Aim to unify the narrow band imaging (NBI) magnifying classification for colorectal tumors: current status in Japan from a summary of the consensus symposium in the 79th Annual Meeting of the Japan Gastroenterological Endoscopy Society.
ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps.
ASGE Technology Committee, Barham K Abu Dayyeh, Nirav Thosani...